E2SR06 EnPulse SR
Implantable Pulse Generator (IPG)
E2SR06 EnPulse SR
Information

Device Survival Probability

E2SR01_E2SR03_E2SR06_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 111.0 mo
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
% Including Normal Battery Depletion 99.5 99.3 98.6 97.5 95.6 91.2 77.8 45.7 10.1 2.7
#   19747 16790 14315 12200 10094 8203 5950 2851 441 134
  • Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
  • Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type IPG
NBD Code SSIR
Max. Delivered Energy N/A
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Connector Style 5/6mm UNI
Serial Number Prefix PNA
Mass 22.5 g
Volume 11.0 cc
Waveform N/A
X-Ray ID PNA
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5/6mm UNI
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 7.2 7.7
Nominal 3.5 V (A, RV) 6.3 7.3
High 5.0 V (A, RV) 4.8 6.1
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppmHide this content

Information

EOL Indication

From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Distribution Data

US Market Release2003-12-18
CE Approval Date2003-09-08
Registered USA Implants1752
Estimated Active USA Implants143
Normal Battery Depletions221
US Market Release2003-12-18
CE Approval Date2003-09-08
Estimated WW Distribution3415
Normal Battery Depletions259
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 1
Electrical Component 1
Information

Elective Replacement (ERI)

Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).

Data as of February 3, 2017

www.medtronic.com/productperformance 476050